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Competitive Generic Therapy Approvals

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359Motegrity, NDA 210166218492Novitium Pharma LLCPrucalopride Tablets, 1 mg and 2 mg12/26/2024YesNo12/26/2024358Tetracaine Hydrochloride, NDA 210821217227Somerset Therapeutics LLCTetracaine Hydrochloride Ophthalmic Solution USP, 0.5%12/20/2024Yes 357ProvayBlue, NDA 204630216959RK Pharma Inc.Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL)12/17/2024NoN/AN/A356Rectiv, NDA 021359216452Encube Ethicals Private Limited Nitroglycerin Ointment USP, 0.4%12/16/2024NoN/AN/A355Alrex, NDA 020803216345Amneal EU, LimitedLoteprednol Etabonate Ophthalmic Suspension, 0.2%12/13/2024NoN/AN/A354Miacalcin, NDA 017808212675Fresenius Kabi USA, LLCCalcitonin Salmon Injection USP, 400 I.U. per 2 mL (200 I.U. per mL) Multi-Dose Vial12/5/2024NoN/AN/A353Abilify, NDA 202971216608Mylan Pharmaceuticals, Inc.Aripiprazole for Extended-Release Injectable Suspension, 300 mg/vial and 400 mg/vial, Single-Dose Vial12/3/2024NoN/AN/A352Atropine Sulfate, NDA 209260215005Somerset Therapeutics LLCAtropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL) Multiple-Dose Vials11/29/2024NoN/AN/A351Rectiv, NDA 021359212222Acrux DDS Pty LtdNitroglycerin Ointment USP, 0.4%11/29/2024NoN/AN/A350Provayblue, NDA 204630216955Steriscience Pte. LimitedMethylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single-Dose Ampule11/22/2024NoN/AN/A349Provayblue, NDA 204630217561Nexus Pharmaceuticals LLCMethylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single-Dose Vial11/21/2024NoN/AN/A348Indocin, NDA 017814215899Hikma Pharmaceuticals USA, Inc.Indomethacin Suppositories USP, 50 mg11/19/2024NoN/AN/A347Chromic Chloride in Plastic Container, NDA 018961218538Stira Pharmaceuticals LLCChromic Chloride Injection USP, 40 mcg/10 mL (4 mcg/mL) Single-Dose Vials11/18/2024Yes 346Clomid, NDA 016131216545Rubicon Research Private LimitedClomiphene Citrate Tablets USP, 50 mg11/12/2024NoN/AN/A345Clomid, NDA 016131216739Appco Pharma LLCClomiphene Citrate Tablets USP, 50 mg11/8/2024YesNo11/19/2024344Cetraxal, NDA 021918217887IdentiRx, LLCCiprofloxacin Otic Solution, 0.2% (Single-Dose Vial)11/5/2024YesNo12/13/2024343Emflaza, NDA 208684216720Upsher-Smith Laboratories, LLC Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg11/5/2024NoN/AN/A342Radicava, NDA 209176217565XGen Pharmaceuticals DJB Inc.Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Vials10/31/2024NoN/AN/A341Eprontia, NDA 214679217795Alkem Laboratories LimitedTopiramate Oral Solution, 25 mg/mL10/31/2024NoN/AN/A340Nicardipine Hydrochloride, NDA 022276215406Amneal EU, LimitedNicardipine Hydrochloride Injection USP, 25 mg/10 mL (2.5 mg/mL) Single-Dose Vial10/31/2024Yes No339Cyclophosphamide, NDA 212501216783Nexus Pharmaceuticals LLCCyclophosphamide Injection, 500 mg/2.5 mL (200 mg/mL) and 1 gram/5 mL (200 mg/mL) per Multiple-Dose Vials10/29/2024NoN/AN/A338Estrogel, NDA 021166217882Novitium Pharma LLCEstradiol Gel, 0.06%10/23/2024NoN/AN/A337Zinc Chloride, NDA 018959216152Somerset Therapeutics LLCZinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL) Single-Dose Vials10/16/2024YesNo10/16/2024336Akovaz, NDA 208289217721Hikma Pharmaceuticals USA, Inc.Ephedrine Sulfate Injection USP, 25 mg/5 mL (5 mg/mL) Single-Dose Prefilled Syringes10/11/2024YesNo12/20/2024335Brevital Sodium, NDA 011559215488Steriscience Pte. LimitedMethohexital Sodium for Injection USP, 500 mg/vial10/3/2024YesNo12/12/2024334Chantix, NDA 021928215931Dr. Reddy's Laboratories LimitedVarenicline Tablets, 0.5 mg and 1 mg10/1/2024NoN/AN/A333Keflet, NDA 050440218947Alkem Laboratories LimitedCephalexin Tablets USP, 250 mg and 500 mg9/27/2024YesNo10/11/2024
(by ANDA 218817)332Keflet, NDA 050440218817Aurobindo Pharma LimitedCephalexin Tablets USP, 250 mg and 500 mg9/27/2024YesNo10/11/2024331Denavir, NDA 020629212368Padagis Israel Pharmaceuticals LTDPenciclovir Cream, 1%9/27/2024NoN/AN/A330Dexmedetomidine, NDA 206628218112Somerset Therapeutics LLCDexmedetomidine Injection USP, 400 mcg/4 mL (100 mcg/mL) and 1000 mcg/10 mL (100 mcg/mL) Multi-dose Vials9/24/2024YesNo10/1/2024329Nicardipine in Sodium Chloride, NDA 22276215592Cipla LimitedNicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Containers9/24/2024YesNo11/22/2024328Miacalcin, NDA 017808213766Cipla LimitedCalcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial9/20/2024NoN/AN/A327Nubain, NDA 18024216049Somerset Therapeutics LLCNalbuphine Hydrochloride Injection, 100 mg/10mL (10 mg/mL) and 200 mg/10 mL (20 mg/mL) Multiple-dose Vials9/19/2024YesNo10/1/2024326Nubain, NDA 18024216050Somerset Therapeutics LLCNalbuphine Hydrochloride Injection, 10 mg/mL and 20 mg/mL Single-dose Ampules9/19/2024YesNo9/25/2024325Theo-Dur, NDA 85328215312Strides Pharma Global Pte LimitedTheophylline Extended-Release Tablets, 300 mg and 450 mg 9/5/2024Yes - 300 mg
No - 450 mgNo9/27/2024324Solu-Cortef, NDA 09866214050Cipla LimitedHydrocortisone Sodium Succinate Injection USP, 100 mg/vial, Single-Dose Vial9/5/2024YesNo9/26/2024323Gocovri, NDA 208944214897Zydus Worldwide DMCCAmantidine Extended-release Capsules, 68.5 mg8/26/2024NoN/AN/A322Advil Dual Action with Acetaminophen, NDA 211733218247Dr. Reddy's Laboratories LimitedAcetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)8/23/2024NoN/AN/A321Asacol HD, NDA 21830213191Teva Pharmaceuticals Inc.Mesalamine Delayed-release Tablets USP, 800 mg8/22/2024YesNo8/22/2024320Lucemyra, NDA 209229218613Indoco Remedies LimitedLofexidine Tablets, 0.18 mg8/20/2024YesNo8/28/2024319ERY-TAB
ANDA 062298211975Torrent Pharma Inc.Erythromycin Delayed-Release Tablets USP, 333 mg8/13/2024YesNo10/24/2024318Ingrezza, NDA 209241216137Zydus Worldwide DMCCValbenazine Capsules, 40 mg, 60 mg and 80 mg8/7/2024NoN/AN/A317Pred Forte, NDA 17011216935Lupin LimitedPrednisolone Acetate Ophthalmic Suspension USP, 1%8/2/2024YesNo10/11/2024316Carafate Oral Suspension, NDA 19183212769Hikma Pharmaceuticals USA Inc.Sucralfate Oral Suspension, 1 g/10 mL7/23/2024NoN/AN/A315Thiola EC, NDA 211843216456Teva Pharmaceuticals Inc.Tiopronin Delayed-Release Tablets, 100 mg and 300 mg7/22/2024NoN/AN/A314Halaven, NDA 201532214850Long Grove Pharmaceuticals LLCEribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-dose Vials7/18/2024NoN/AN/A313Zinc Sulfate, NDA 209377216135Somerset Therapeutics LLCZinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package7/17/2024NoN/AN/A312Tazorac, NDA 21184217075Padagis Israel Pharmaceuticals Ltd.Tazarotene Cream, 0.05%7/15/2024YesNo9/9/2024311Divigel, NDA 022038216055Amneal Pharmaceuticals LLCEstradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet)7/12/2024NoN/AN/A310Potassium Phosphates, NDA 212832217726Somerset Therapeutics LLCPotassium Phosphates Injection USP, Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL), Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials7/11/2024NoN/AN/A309Alrex, NDA 20803215203Padagis US LLCLoteprednol Etabonate Ophthalmic Suspension, 0.2%7/10/2024NoN/A 308Endari, NDA 208587215647Novitium Pharma LLCL-Glutamine Oral Powder, 5 grams/packet7/8/2024NoN/AN/A307Zinc Sulfate, NDA 209377214597Nivagen Pharmaceuticals, IncZinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL), 25 mg/5 mL (5 mg/mL) and 10 mg/10 mL (1 mg/mL) Pharmacy Bulk Package7/5/2024NoN/AN/A306Atropine Sulfate, NDA 214652215969Somerset Therapeutics LLCAtropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Vials7/3/2024NoN/AN/A305Exparel, NDA 22496214348Jiangsu Hengrui Pharmaceuticals Co., Ltd.Bupivacaine Liposome Injectable Suspension, 133 mg/10 mL (13.3 mg/mL) and 266 mg/20 mL (13.3 mg/mL) Single -dose Vials7/1/2024NoN/AN/A304Atropine Sulfate, NDA 206289215618Somerset Therapeutics LLCAtropine Sulfate Ophthalmic Solution USP, 1%7/1/2024NoN/AN/A303Astepro OTC, NDA 213872216576ANDA ApplicantAzelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy)6/5/2024NoN/AN/A302Astepro OTC, NDA 213872216421Apotex Inc.Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy and Children's Allergy)5/29/2024NoN/AN/A301Halog, NDA 17823217671Encube Ethicals Private LimitedHalcinonide Topical Solution USP, 0.1%5/29/2024YesYesN/A300Phenylephrine, NDA 207926215183Caplin Steriles LimitedPhenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% and 10%5/23/2024NoN/AN/A299Timolol Maleate, NDA 20963216343Amneal EU, LimitedTimolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%5/23/2024YesYesN/A298Somatuline Depot, NDA 22074217193InvaGen Pharmaceuticals, Inc.Lanreotide Injection, 60 mg/0.2 mL, 90 mg/0.3 mL, 120 mg/0.5 mL, Single-Dose Prefilled Syringes5/21/2024NoN/AN/A297ProAir HFA, NDA 21457212447Armstrong Pharmaceuticals Inc.Albuterol Sulfate Inhalation Aerosol, 90 mcg (base) per actuation5/21/2024NoN/AN/A296Calcium Gluconate in Sodium Chloride, NDA 208418216611Amneal EU, LimitedCalcium Gluconate Injection USP, 1,000 mg/10 mL (100 mg/mL) Single-Dose Vials (10 mL Fill) and Calcium Glconate Injection USP, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials (50 mL Fill)5/10/2024NoN/AN/A295Zegerid OTC, NDA 22283217784Dr. Reddy's Laboratories LimitedOmeprazole and Sodium Bicarbonate Powder for Oral Suspension, 20 mg/1680 mg (OTC)5/9/2024YesYesN/A294Dexamethasone, NDA 88306216284Zydus Pharmaceuticals (USA) Inc.Dexamethasone Tablets USP, 1 mg5/9/2024NoN/AN/A293Vasostrict, NDA 204485213988Dr. Reddy's Laboratories LimitedVasopressin Injection USP, 20 Units/mL Single-Dose Vials5/8/2024NoN/AN/A292Radicava, NDA 209176218354Long Grove Pharmaceuticals LLCEdaravone Injection, 30 mg/100 ml (0.3 mg/mL), Single-Dose Bag5/6/2024NoN/AN/A291Radicava, NDA 209176215917Dr. Reddy's Laboratories LimitedEdaravone Injection, 60 mg/100 ml (0.6 mg/mL), Single-Dose Bag5/6/2024NoN/AN/A290Cupric Chloride in Plastic Container, NDA 18960217626Stira Pharmaceuticals LLCCupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Single-Dose Vials4/30/2024Yes 6/24/2024
(by ANDA 216113)289Cupric Chloride in Plastic Container, NDA 18960216113Somerset TherapeuticsCupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Single-Dose Vials4/30/2024YesNo6/24/2024288Isopto Atropine, NDA 208151217791Somerset TherapeuticsAtropine Sulfate Ophthalmic Solution USP, 1%4/29/2024YesNo6/7/2024287Nasonex, NDA 215712217438Apotex Inc.Mometasone Furoate Nasal Spray, 50 mcg/spray (OTC)4/23/2024NoN/AN/A286Votrient, NDA 22465218231Novugen Oncology Sdn. Bhd.Pazopanib Tablets, 200 mg4/23/2024NoN/AN/A285EstroGel, NDA 21166216160Solaris Pharma CorporationEstradiol Gel, 0.06%4/22/2024YesNo4/26/2024284Tranexamic Acid, NDA 212020216877Nexus Pharmaceuticals LLCTranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL)4/16/2024NoN/AN/A283Miacalcin, NDA 017808215715Dr. Reddy's Laboratories LimitedCalcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial4/11/2024NoN/AN/A282Oracea, NDA 218034218034Dr. Reddy's Laboratories LimitedDoxycycline Capsules, 40 mg4/8/2024NoN/AN/A281Narcan, NDA 16636213573Fresenius Kabi USA, LLCNaloxone Hydrochloride Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Prefilled Syringe4/2/2024NoN/AN/A280Sodium Acetate, NDA 18893216920Hikma Pharmaceuticals USA, IncSodium Acetate Injection USP, 40 mEq/20 mL (2 mEq/mL)3/15/2024YesNo5/20/2024279Entadfi, NDA 215423218232Zydus Worldwide DMCCFinasteride and Tadalafil Capsules, 5 mg/5 mg3/15/2024YesYesN/A278Rectiv, NDA 21359216103Cosette Pharmaceuticals, IncNitroglycerin Ointment USP, 0.4%2/16/2024YesNo2/23/2024277Lumify, NDA 208144216361Dr. Reddy's Laboratories SABrimonidine Tartrate Ophthalmic Solution, 0.025%2/16/2024NoN/AN/A276Dilaudid, NDA 019034216899Hikma Pharmaceuticals USA, IncHydromorphone Hydrochloride Injection USP, 0.2 mg/mL Single-Dose Prefilled Syringe2/9/2024NoN/AN/A275Dexamethasone, ANDA 087916216283Zydus Pharmaceuticals (USA) IncDexamethasone Tablets USP, 2 mg2/7/2024NoN/AN/A274Thiola EC, NDA 211843216990Torrent Pharmaceuticals LtdTiopronin Delayed-Release Tablets, 100 mg and 300 mg1/30/2024NoN/AN/A273Astagraf XL, NDA 204096215012Chengdu Suncadia Medicine Co., LimitedTacrolimus Extended-Release Capsules, 0.5 mg, 1 mg, and 5 mg1/25/2024NoN/AN/A272Carafate, NDA 019183213549PD Partners III, LLCSucralfate Oral Suspension, 1 g/10 mL1/17/2024NoN/AN/A271BiDil, NDA 020727215988i3 Pharmaceuticals, LLCIsosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg1/17/2024NoN/AN/A270Nuplazid, NDA 210793214493Zydus Pharmaceuticals (USA) Inc.Pimavanserin Capsules, 34 mg1/16/2024NoN/AN/A269Nuplazid, NDA 207318214502Zydus Pharmaceuticals (USA) Inc.Pimavanserin Tablets, 10 mg1/16/2024NoN/AN/A268Indocin, NDA 018332217883Novitium Pharma LLCIndomethacin Oral Suspension, USP 25 mg/5 mL1/12/2024YesNo1/12/2024267FML, NDA 016851216348Amneal EU, LimitedFluorometholone Ophthalmic Suspension USP, 0.1%1/9/2024YesNo1/9/2024266Amicar, NDA 015230213213Sunny Pharmtech Inc.Aminocaproic Acid Oral Solution USP, 0.25 grams/mL12/27/2023NoN/AN/A265Alrex, NDA 020803215550Lupin LimitedLoteprednol Etabonate Ophthalmic Suspension, 0.2%12/26/2023NoN/AN/A264Prezista, N021976214085Zydus Pharmaceuticals (USA) Inc.Darunavir Tablets, 800 mg12/13/2023NoN/AN/A263ProvayBlue, NDA 204630215636Zydus Pharmaceuticals (USA) Inc.Methylene Blue Injection USP, 10 mg/2 mL (5 mg/mL) and 50 mg/10 mL (5 mg/mL) Single-Dose Vials12/5/2023NoN/AN/A262Lotemax, NDA 202872213956Slayback Pharma LLCLoteprednol Etabonate Ophthalmic Gel, 0.5%11/29/2023NoN/AN/A261Foscavir, NDA 020068213987Beijing Secure Pharmaceutical Co., Ltd.Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion11/29/2023NoN/AN/A260Corlanor, NDA 206143213442Zydus Pharmaceuticals (USA) Inc.Ivabradine Tablets, 5 mg and 7.5 mg11/29/2023NoN/AN/A259Condylox, NDA 020529211871Padagis US LLCPodofilox Gel 0.5%11/22/2023YesNo12/13/2023258Zovirax, NDA 021478212361Alembic Pharmaceuticals LimitedAcyclovir Cream, 5%11/21/2023YesNo12/15/2023257Revex, NDA 020459216007Chengdu Shuode Pharmaceutical Co., Ltd.Nalmefene Hydrochloride Injection, 100 mcg/mL and 2 mg/2 mL (1 mg/mL) Single-Dose Vials11/15/2023NoN/AN/A256Divigel, NDA 022038216524Padagis Israel Pharmaceuticals Ltd.Estradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet)11/14/2023NoN/AN/A255AN Sulfur Colloid, NDA 017858213516Jubilant DraxImage Inc.Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection11/9/2023YesNo12/4/2023254Efudex, NDA 016831215612Encube Ethicals Private LimitedFluorouracil Topical Solution USP, 5%11/2/2023YesYesN/A253Aczone, NDA 207154212657Padagis US LLCDapsone Gel, 7.5%11/1/2023NoN/AN/A252Principen, NDA 050056216554Aurobindo Pharma LimitedAmpicillin Capsules USP, 250 mg and 500 mg10/31/2023YesNo12/11/2023251Calcium Gluconate in Sodium, NDA 208418217689Somerset TherapeuticsCalcium Gluconate Injection USP, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials (50 mL Fill) and Calcium Gluconate Injection USP, 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package (100 mL Fill)10/19/2023Yes - 5,000 mg/50 mL (100 mg/mL); No-10,000 mg/100 mL (100 mg/mL)No10/20/2023250Votrient, NDA 022465215837Sun Pharmaceutical IndustriesPazopanib Tablets, 200 mg10/19/2023NoN/AN/A249Votrient, NDA 022465217517Teva PharmaceuticalsPazopanib Tablets, 200 mg10/19/2023NoN/AN/A248Tranexamic Acid, NDA 212020217155Amneal Pharmaceuticals of New York, LLCTranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL)10/16/2023YesNo10/19/2023247Potassium Phosphates, NDA 212832216344Amneal Pharmaceuticals of New York, LLCPotassium Phosphates Injection USP, Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL), Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; Phosphorus 150 mmol/50 mL (3 mmol/mL) and Potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials10/10/2023NoN/AN/A246Bridion, NDA 022225214290Zydus Pharmaceuticals (USA) Inc.Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vials10/4/2023NoN/AN/A245Glucotrol, NDA 017783214874Rubicon Research Private LimitedGlipizide Tablets USP, 2.5 mg10/3/2023YesNo10/18/2023244Potassium Phosphates, NDA 212832216274American Regent, Inc.Potassium Phosphates Injection USP, phosphorus 15 mmol/5 mL (3 mmol/mL) and potassium 22 mEq/5 mL (4.4 mEq/mL), phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; phosphorus 150 mmol/50 mL (3 mmol/mL) and potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials10/2/2023YesNo10/16/2023 - Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL) Single-dose Vials; 10/13/2023 - Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; Phosphorus 150 mmol/50 mL (3 mmol/mL) and Potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials243Xeljanz, NDA 213082216878Slayback Pharma LLCTofacitinib Oral Solution, 1 mg/mL9/25/2023NoN/AN/A242AK-FLUOR, 10% and 25%, NDA 022186215709Nexus Pharmaceuticals Inc.Fluorescein Injection USP, 500 mg/5 mL (100 mg/mL) and 500 mg/2 mL (250 mg/mL) Single-Dose Vials9/25/2023YesNo10/24/2023241Ortho Evra, NDA 21180214594Zydus Noveltech Inc.Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day9/14/2023NoN/AN/A240Gadavist, NDA 201277216081Jiangsu Hengrui Pharmaceuticals Co., Ltd.Gadobutrol Injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL) Imaging Bulk Package9/8/2023YesNo11/1/2023239Calcium Gluconate in Sodium Chloride, NDA 208418217174Amneal Pharmaceuticals LLCCalcium Gluconate in Sodium Chloride Injection, 1000 mg/50 mL and 2000 mg/100 mL (20 mg/mL) Single-Dose Containers9/5/2023YesNo9/12/2023238Vyvanse, NDA 021977215330Rhodes Pharmaceutical L.P.Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg8/25/2023NoN/AN/A237Combigan, NDA 021398215230Syneos Health, LLCBrimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5%8/25/2023NoN/AN/A236Vyvanse, NDA 021977214547Norwich Pharmaceuticals, Inc.Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg8/25/2023NoN/AN/A235Dexamethasone, ANDA 088316217695Apotex Corp.Dexamethasone Tablets USP, 1 mg8/23/2023YesNo11/1/2023234Zinc Sulfate, NDA 209377217074Zydus Pharmaceuticals (USA) Inc.Zinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL), and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package Vials8/22/2023NoN/AN/A233Retin-A-Micro, NDA 020475215609Encube Ethicals Private LimitedTretinoin Gel (Microsphere), 0.08%8/22/2023YesNo9/8/2023232Calcium Gluconate in Sodium Chloride, NDA 208418216541B. Braun Medical, Inc.Calcium Gluconate Injection 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package8/21/2023YesNo11/2/2023231Balcoltra, NDA 208612214640Xiromed Pharma Espana, S.L.Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 0.1 mg/0.02 mg and 75 mg8/16/2023NoN/AN/A230Zonalon, NDA 020126212357Amneal Pharmaceuticals, LLCDoxepin Hydrochloride Cream, 5%8/16/2023NoN/AN/A229Thiola EC, NDA 211843216278Amneal Pharmaceuticals of New York, LLCTiopronin Delayed-Release Tablets, 300 mg8/15/2023NoN/AN/A228Lithium Citrate, NDA 018421218036Rubicon Research Private LimitedLithium Oral Solution USP, 8 mEq/5 mL8/14/2023YesNo9/20/2023227Potassium Chloride, ANDA 080205217704Nexus Pharmaceuticals Inc.Potassium Chloride for Injection Concentrate USP, 20 mEq/10 mL (2 mEq/mL) and 40 mEq/20 mL (2 mEq/mL) Single-Dose Vials8/14/2023YesNo9/12/2023226Lexette, NDA 210566215266Padagis US LLCHalobetasol Propionate Topical Foam, 0.05%8/11/2023NoN/AN/A225Lotemax, NDA 2028722215384Sun Pharmaceutical Industries, Inc.Loteprednol Etabonate Ophthalmic Gel, 0.5%8/9/2023NoN/AN/A224Denavir, NDA 020629216981Torrent Pharma Inc.Penciclovir Cream, 1%8/7/2023YesNo9/1/2023223Vancomycin, NDA 209481217401Eugia US LLCVancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial (Single-Dose vials)8/4/2023NoN/AN/A222Indocin, NDA 017814216184Zydus Worldwide DMCCIndomethacin Suppositories USP, 50 mg8/2/2023YesNo8/3/2023221Azopt, NDA 020816211914Padagis USA LLCBrinzolamide Ophthalmic Suspension USP, 1%7/28/2023YesNo10/10/2023220Cardene, NDA 019488215377Senores Pharmaceuticals, Inc.Nicardipine Hydrochloride Capsules, 20 mg and 30 mg7/17/2023YesNo9/19/2023219Sodium Phenylacetate and Sodium Benzoate, NDA 215025217526Navinta LLCSodium Phenylacetate and Sodium Benzoate Injection, 10% / 10% (2g - 2 g/20 mL [0.1 g - 0.1 g/mL])Single-Dose Vial7/14/2023YesNo9/22/2023218Sodium Chloride 23.4%, NDA 019329217796Fresenius Kabi USA, LLC23.4% Sodium Chloride Injection USP, 800 mEq/200 mL (4 mEq/mL) Pharmacy Bulk Package7/11/2023YesN/A7/27/2023217Sterile Water, NDA 018801217536Nexus Pharmaceuticals Inc.Sterile Water for Injection USP, 20 mL Single-Dose Vials7/11/2023YesYesN/A216Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride, NDA 050786217511RinconPharma LLCBismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125mg/125 mg7/3/2023YesNo7/3/2023215Vancomycin Hydrochloride, NDA 209481217489Hikma Pharmaceuticals USA Inc.Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial Single-Dose Vial6/29/2023YesNo8/16/2023214Vancocin Hydrochloride, ANDA 061667215338Amneal Pharmaceuticals LLCVancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL (50 mg/mL)6/23/2023YesNo6/23/2023213Nasonex, NDA 215712217460Amneal Pharmaceuticals LLCMometasone Furoate Nasal Spray, 50 mcg/spray (OTC)6/14/2023YesYesN/A212Katerzia, NDA 211340215035Amneal Pharmaceuticals LLCAmlodipine Benzoate Oral Suspension, 1 mg/mL (150 mL)6/13/2023NoN/AN/A211Fleqsuvy, NDA 215602217252Slayback Pharma LLCBaclofen Oral Suspension, 25 mg/5 mL (5 mg/mL)6/8/2023NoN/AN/A210Foscarnet Sodium Injection, 6,000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion, NDA 020068213807Emcure Pharmaceuticals Ltd.Foscarnet Sodium Injection, 6,000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion6/5/2023NoN/AN/A209Arranon, NDA 021877215057Nexus Pharmaceuticals Inc.Nelarabine Injection, 250 mg/50 mL (5 mg/mL) Single-Dose Vial6/2/2023NoN/AN/A208Fosamax, NDA 021575214512Novitium Pharma LLCAlendronate Sodium Oral Solution, 70 mg (base)/75 mL5/11/2023YesNo5/24/2023207Dexamethasone, ANDA 081916217696Novitium Pharma LLCDexamethasone Tablets USP, 2 mg5/9/2023NoN/AN/A206Calcium DisodiumVersenate, NDA 008922216435Casper Pharma LLCEdetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL) Single-Dose Vial5/2/2023YesNo7/12/2023205Celontin, NDA 010596217213Novitium Pharma LLCMethsuximide Capsules USP, 300 mg5/1/2023YesNo5/1/2023204Dexamethasone, ANDA 087916217538Bionpharma Inc.Dexamethasone Tablets USP, 2 mg4/26/2023NoN/AN/A203Tazorac, NDA 020600213079Padagis Israel Pharmaceuticals Ltd.Tazarotene Gel, 0.05% and 0.1%4/25/2023NoN/AN/A202Alrex, NDA 020803215933Akorn Operating Company LLCLoteprednol Etabonate Ophthalmic Suspension, 0.2%4/12/2023YesYesN/A201Uceris, NDA 205613215328Padagis Israel Pharmaceuticals Ltd.Budesonide Rectal Foam, 2 mg/dose4/12/2023YesNo4/27/2023200Paraflex, NDA 011300214702Corepharma, LLCChlorzoxazone Tablets USP, 250 mg4/10/2023NoN/AN/A199Arranon, NDA 021877216346Amneal Pharmaceuticals LLCNelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial4/4/2023NoN/AN/A198Alphagan P, NDA 021262215225Syneos Health, LLCBrimonidine Tartrate Ophthalmic Solution, 0.15%3/29/2023NoN/AN/A197Amitiza, NDA 021908214131Zydus Pharmaceuticals (USA) Inc.Lubiprostone Capsules, 8 mcg and 24 mcg3/23/2023NoN/AN/A196Enstilar, NDA 207589214688Glenmark Pharmaceuticals Inc., USACalcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064%3/21/2023NoN/AN/A195Tazorac, NDA 020600213644Solaris Pharma CorporationTazarotene Gel, 0.05% and 0.1%3/20/2023NoN/AN/A194Prednisolone, ANDA 080354215673Aurobindo Pharma LimitedPrednisolone Tablets USP, 5 mg3/17/2023YesNo5/22/2023193Arranon, NDA 021877214809Shorla Pharma LimitedNelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial3/3/2023NoN/AN/A192Advil Dual Action with Acetaminophen, NDA 211733214836L. Perrigo CompanyAcetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)2/28/2023NoN/AN/A191Thiola EC, NDA 211843217219Par Pharmaceutical Inc.Tiopronin Delayed-Release Tablets, 100 mg and 300 mg2/24/2023NoN/AN/A190Zonalon, NDA 021026215408Teva Pharmaceutical Development, Inc.Doxepin Hydrochloride Cream, 5%2/17/2023YesNo2/17/2023189Trokendi XR, NDA 201635216167Zydus Pharmaceuticals (USA) Inc.Topiramate Extended-Release Capsules, 200 mg2/9/2023NoN/AN/A188Parafon Forte DSC, NDA 011529212047Appco Pharma LLCChlorzoxazone Tablets USP, 375 mg and 750 mg1/27/2023NoN/AN/A187Phenylephrine Hydrochloride, NDA 207926216496Mankind Pharma LimitedPhenylephrine Hydrochloride Ophthalmic Solution USP, 10%1/11/2023YesNo1/18/2023186Arranon, NDA 021877216038MeithealPharmaceuticals, Inc.Nelarabine Injection, 250 mg/50 mL (5 mg/mL) Single-Dose Vial1/10/2023NoN/AN/A185Orfadin, NDA 021232215908Torrent Pharma Inc.Nitisinone Capsules, 20 mg1/9/2023YesYesN/A184Zinc Sulfate, NDA 209377216145Fresenius Kabi USA, LLCZinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package12/27/2022Yes (10 mg/10 mL); No (30 mg/10 mL); No (25 mg/5 mL)No2/15/2023183Cupric Sulfate, NDA 019350216324American Regent, Inc.Cupric Sulfate Injection USP, 4 mg/10 mL (0.4 mg/mL) Pharmacy Bulk Package12/26/2022YesYesN/A182Uptravi, NDA 207947214302Zydus Worldwide DMCCSelexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg12/21/2022NoN/AN/A181Perforomist, NDA 22007215621Slayback Pharma LLCFormoterol Fumarate Solution 20 mcg/2 mL per Unit Dose Vial12/13/2022NoN/AN/A180Potassium Chloride, NDA 206814211665Strides Pharma Global Pte LimitedPotassium Chloride Oral Solution USP, 40 mEq/15 mL (20%)11/17/2022NoN/AN/A179AmBisome Liposome, NDA 050740214010Eugia US LLCAmphotericin B Injection, 50 mg/vial Single-Dose Vial11/17/2022NoN/AN/A178Durezol, NDA 022212214894Dr. Reddy's Laboratories LimitedDifluprednate Ophthalmic Emulsion, 0.05%11/16/2022NoN/AN/A177Calcium Gluconate, NDA 208418213071Nivagen Pharmaceuticals, Inc.Calcium Gluconate Injection USP, 1,000 mg per 10 mL (100 mg per mL) Single-Dose Vial10/14/2022YesNo11/6/2022176Briviact, NDA 205836214501Zydus Pharmaceuticals (USA) Inc.Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg10/3/2022NoN/AN/A175Phenylephrine Hydrochloride, NDA 207926216859Mankind Pharma LimitedPhenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% w/v (2 mL fill)9/29/2022YesNo10/7/2022174Pathocil, NDA 050011216845Aurobindo Pharma USA, Inc.Dicloxacillin Sodium Capsules USP, 250 mg and 500 mg9/23/2022YesNo9/30/2022173Timoptic in Ocudose, NDA 019463216533Ingenus Pharmaceuticals, LLCTimolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials9/13/2022NoN/AN/A172Tazorac, NDA 020600215433Cosette Pharmaceuticals, Inc.Tazarotene Gel, 0.05%9/13/2022YesNo9/14/2022171Tazorac, NDA 020600214136Cosette Pharmaceuticals, Inc.Tazarotene Gel, 0.01%9/13/2022YesNo9/14/2022170Carafate, NDA 19183212913Mylan Pharmaceuticals, Inc.Sucralfate Oral Suspension, 1 g/10 mL9/12/2022NoN/AN/A169Dexamethasone, ANDA 087916216295Amneal Pharmaceuticals LLCDexamethasone Tablets USP, 2 mg9/8/2022YesNo9/9/2022168Lyrica CR, NDA 209501215577Zydus Pharmaceuticals (USA) Inc.Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, and 330 mg8/26/2022NoN/AN/A167Cetrotide, NDA 021197215737Akorn Operating Company LLCCetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose8/12/2022YesNo10/24/2022166Divigel, NDA 022038211783Chemo Research S.L.Estradiol Gel, 0.1%8/10/2022YesNo10/10/2022165Clindagel, NDA 050782214668Amneal Pharmaceuticals LLCClindamycin Phosphate Gel USP, 1%8/5/2022YesNo8/5/2022164Bactroban, NDA 050746212465Padagis Israel Pharmaceuticals Ltd.Mupirocin Cream USP, 2%8/3/2022NoN/AN/A163Taytulla, NDA 204426213418Glenmark Pharmaceuticals LimitedNorethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg7/27/2022NoN/AN/A162Vasostrict, NDA 204485211857Amphastar Pharmaceuticals, Inc.Vasopressin Injection USP, 20 Units/mL Single-Dose Vials7/18/2022NoN/AN/A161Nalfon, NDA 017604214475Rising Pharma Holdings, Inc.Fenoprofen Calcium Capsules USP, 400 mg7/18/2022YesNo8/15/2022160Atropine Sulfate, NDA 206289214752Amneal Pharmaceuticals LLCAtropine Sulfate Ophthalmic Solution USP, 1%7/14/2022NoN/AN/A159Isordil, NDA 012093215723Rubicon Research Private LimitedIsosorbide Dinitrate Tablets USP, 40 mg7/8/2022NoN/AN/A158Neostigmine Methylsulfate, NDA 203629216291Dr. Reddy's Laboratories LimitedNeostigmine Methylsulfate Injection USP, 3 mg/3 mL (1 mg/mL) Single-Dose Prefilled Syringes7/6/2022YesNo7/25/2022157Plasma-Lyte 148 in Water,NDA 017378215370Fresenius Kabi USA, LLCMultiple Electrolytes Injection Type 1 USP, pH 5.5, Single-Dose Containers6/29/2022YesYesN/A156Carbaglu, NDA 022562213395Navinta LLCCarglumic Acid Tablets for Oral Suspension, 200 mg6/22/2022NoN/AN/A155Narcan, NDA 208411211951Padagis Israel Pharmaceuticals Ltd.Naloxone Hydrochloride Nasal Spray, 4 mg/spray6/21/2022NoN/AN/A154Infants’ Advil, NDA 020812214071Strides Pharma Inc.Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC)6/9/2022YesYesN/A153Plasma-Lyte A, NDA017378215371Fresenius Kabi USA, LLCMultiple Electrolytes Injection Type 1 USP, pH 7.4, Single-Dose Containers6/8/2022YesYesN/A152Epiduo Forte, NDA 207917214553Zydus Pharmaceuticals (USA) Inc.Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%6/3/2022NoN/AN/A151Epiduo Forte, NDA 207917212464Padagis US, LLCAdapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%5/31/2022NoN/AN/A150Atropine Sulfate, NDA 214652216120American Regent, Inc.Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Vials5/26/2022YesNo8/2/2022149Brovana, NDA 021912215385Sun Pharmaceutical Industries LtdArformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vial5/26/2022NoN/AN/A148Alimta, NDA 021462214073Zydus Pharmaceuticals (USA) Inc.Pemetrexed for Injection USP, 1000 mg/vial5/25/2022NoN/AN/A147Lexiscan, NDA 022161214252International Medication Systems, LimitedRegadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe5/23/2022NoN/AN/A146Visipaque, NDA 20351214271Jiangsu Hengrui Pharmaceuticals Co., Ltd.Iodixanol Injection USP, 270 mg Iodine/mL and 320 mg Iodine/mL Single Dose Bottles5/19/2022YesNo7/13/2022145Pentasa, NDA 020049214585Sun Pharmaceutical Industries Inc.Mesalamine Extended Release Capsules USP, 500 mg5/11/2022YesNo5/18/2022144Brovana, NDA 021912214779Alembic Pharmaceuticals LimitedArformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial5/10/2022NoN/AN/A143Zinc Sulfate, NDA 209377216249Gland Pharma LimitedZinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL)5/3/2022

Yes

6/27/2022 (30 mg/10 mL (3 mg/mL)) 25 mg/5 mL (5 mg/mL)142Targretin, NDA 021056215398Amneal Pharmaceuticals LLCBexarotene Gel, 1%4/27/2022YesNo5/17/2022141AquaMEPHYTON, NDA 012223214596Cipla LimitedPhytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Vials4/22/2022YesNo5/3/2022140AquaMEPHYTON, NDA 012223212424Cipla LimitedPhytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Ampules4/22/2022Yes 5/3/2022 (by ANDA 214596)139Sinequan, NDA 016798213796Edenbridge Pharmaceuticals, LLCDoxepin Hydrochloride Capsules USP, 150 mg4/19/2022YesNo5/2/2022138Mestinon, NDA 015193212405Milla Pharmaceuticals, IncPyridostigmine Bromide Solution USP, 60 mg/5 mL4/19/2022NoN/AN/A137Lexiscan, NDA 022161213210Dr. Reddy's Laboratories, Inc.Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe4/11/2022NoN/AN/A136Ganirelix Acetate, NDA 021057212613Amphastar Pharmaceuticals, Inc.Ganirelix Acetate Injection, 250 mcg/0.5 mL Prefilled Syringe4/7/2022NoN/AN/A135Noxafil, NDA 205053212500Dr. Reddy's Laboratories, Inc.Posaconazole Delayed-Release Tablets, 100 mg4/7/2022NoN/AN/A134Butalbital and Acetaminophen, ANDA 89988214088Havix Group Inc.Butalbital and Acetaminophen Tablets, 25 mg/325 mg4/7/2022YesYesN/A133BiDil, NDA 020727215586RiconPharma LLCIsosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg4/6/2022YesNo4/12/2022132Revatio, NDA 203109211638Lupin Pharmaceuticals, Inc.Sildenafil for Oral Suspension, 10 mg/mL3/23/2022NoN/AN/A131Carafate, NDA 019183211884VistaPharm, Inc.Sucralfate Oral Suspension, 1 g/10 mL3/15/2022YesNo3/15/2022130Brovana, NDA 021912214736VistaPharm, Inc.Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL, Unit-Dose Vial3/2/2022NoN/AN/A129Apokyn,NDA 021264212025Sage Chemical, Inc.Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use Glass Cartridge2/23/2022YesNo2/25/2022128Veltin, NDA 050803212845Solaris Pharma CorporationClindamycin Phosphate and Tretinoin Gel, 1.2%/0.025%2/10/2022YesNo4/12/2022127Lanoxin, NDA 020405214982Aurobindo Pharma LimitedDigoxin Tablets USP, 0.0625 mg2/8/2022YesNo2/17/2022126Revex, NDA 020459212955Purdue Pharma L.P.Nalmefene Hydrochloride Injection, 2 mg/2 mL (1 mg/mL) Single-Dose Vials2/8/2022YesRelinquishedN/A125Cystadane, NDA 020576210508Lukare Medical, LLCBetaine Anhydrous for Oral Solution, 180 grams/bottle1/28/2022NoN/AN/A124Atropine Sulfate, NDA 021146215342Amneal EU, LimitedAtropine Sulfate Injection USP, 0.5 mg/5 mL (0.1 mg/mL) Single-Dose Syringe1/26/2022NoN/AN/A123Monurol, NDA 050717211881Cipla USA, Inc.Fosfomycin Tromethamine Suspension 3 g (base) Single-Dose Sachet1/26/2022NoN/AN/A122Migranal, NDA 020148214105Amneal Pharmaceuticals LLCDihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial)1/4/2022NoN/AN/A121AmBisome Liposome, NDA 050740212514Sun Pharmaceutical Industries Inc.Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial12/14/2021YesNo2/15/2022120Timoptic, NDA 019463212592Pharmaceutical Project Solutions, Inc.Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials12/13/2021YesNo2/26/2022119Atropine Sulfate, NDA 209260213561Hikma Pharmaceuticals USA Inc.Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL) Multi-Dose Vial12/1/2021NoN/AN/A118Atropine Sulfate, NDA 206289215624ApotexAtropine Sulfate Ophthalmic Solution, USP 1%11/26/2021YesNo11/26/2021117Cystadane, NDA 20576214864Novitium PharmaBetaine Anhydrous for Oral Solution, 180 grams/bottle11/23/2021YesNo2/3/2022116Isordil, NDA 012093211290Par Pharmaceutical, Inc.Isosorbide Dinitrate Tablets USP, 40 mg11/23/2021YesNo12/21/2021115Perforomist, NDA 022007215078Alembic Pharmaceuticals LimitedFormoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial11/22/2021NoN/ANo114Revatio, NDA 203109212312Tris Pharma, Inc.Sildenafil for Oral Suspension, 10 mg/mL11/17/2021NoN/ANo113Arranon, NDA 021877215037Zydus Pharmaceuticals (USA) Inc.Nelarabine Injection, 250 mg/50 mL (5 mg/mL), SingleDose Vial11/17/2021YesNo11/23/2021112Bactroban, NDA 050746213053Aleor Dermaceuticals LimitedMupirocin Cream USP, 2%11/16/2021YesNo12/29/2021111Librax, NDA012750211476Teva Pharmaceuticals USA, Inc.Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg11/2/2021NoN/AN/A110Prexxartan, NDA 209139214102Novitium Pharma, LLCValsartan Oral Solution, 20 mg/5 mL (4 mg/mL)11/2/2021YesYesN/A109Monurol, NDA 050171214554Alkem Laboratories LimitedFosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet10/21/2021No N/A108Decadron, NDA 011664215106Amneal EU, LimitedDexamethasone Tablets USP, 4 mg and 6 mg10/14/2021YesNo4 mg - 10/22/2021; 6 mg - 10/21/2021107Carbaglu, NDA 016636213729Novitium Pharma, LLCCarglumic Acid Tablets for Oral Suspension, 200 mg10/13/2021YesN012/20/2021106Mexitil, NDA 018873214089Aavis PharmaceuticalsMexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg10/1/2021NoN/AN/A105Zomig, NDA 021450212469Padagis US, LLCZolmitriptan Nasal Spray USP, 2.5 mg/spray and 5 mg/spray9/30/2021NoN/AN/A104Absorica, NDA 021951212333Upsher-Smith Laboratories, LLCIsotretinoin Capsules USP, 10 mg, 20 mg, and 30 mg9/21/2021NoN/AN/A103Quinaglute, NDA 016647212589Eywa Pharma, Inc.Quinidine Gluconate Extended-Release Tablets USP, 324 mg9/17/2021YesYesN/A102Paxil, NDA 020710215003Novitium Pharma LLCParoxetine Oral Suspension, 10 mg (base)/5 mL9/3/2021YesNo9/13/2021101Ortho Evra, NDA 021180213977Teva Pharmaceuticals USA, Inc.Onsura (Norelgestromin and Ethinyl Estradiol Transdermal System), 150 mcg/35 mcg per day8/25/2021NoN/AN/A100Aramine, NDA 009509211304Slayback Pharma LLCMetaraminol Bitartrate Injection USP, 100 mg (base)/10 mL (10 mg (base)/mL), Multi-Dose Vial8/24/2021YesYesN/A99Cuprimine, NDA 019853213293InvaGen Pharmaceuticals, Inc.Penicillamine Capsules USP, 250 mg8/19/2021NoN/AN/A98Clindagel, NDA 050782212842Solaris Pharma CorporationClindamycin Phosphate Gel USP, 1%8/13/2021NoN/AN/A97Loperamide Hydrochloride, NDA 21855213070Strides Pharma, Inc.Loperamide Hydrochloride Capsules USP, 2 mg (OTC)8/11/2021YesNo10/22/202196Paraflex, NDA 011300215158Havix Group, Inc.Chlorzoxazone Tablets USP, 250 mg7/29/2021YesNo9/30/202195Daraprim, NDA 008578211271AlvogenPyrimethamine Tablets USP, 25 mg7/27/2021YesNo10/4/202194Ery-Tabs, ANDA 062298211975Torrent Pharma Inc.Erythromycin Delayed-Release Tablets USP, 250 mg and 500 mg7/26/2021YesNo10/4/202193Atropine Sulfate, NDA 021146212868Accord Healthcare Inc.Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe7/26/2021YesNo7/30/202192Taytulla, NDA 204426214292Amneal PharmaceuticalsNorethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg7/20/2021NoN/AN/A91Theophylline, ANDA 90430212184Glenmark Pharmaceuticals LimitedTheophylline Extended-Release Tablets, 450 mg6/3/2021YesNo6/11/202190Thorazine, NDA 009149214542Genus Lifesciences Inc.Chlorpromazine Hydrochloride Oral Concentrate USP, 30 mg/mL and 100 mg/mL6/2/2021YesNo8/2/202189Miacalcin Injection, NDA 017808212416Custopharm, Inc.Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial5/14/2021YesNo5/14/202188Revatio, NDA 203109213014Hetero Labs LimitedSildenafil for Oral Suspension, 10 mg/mL5/11/2021NoN/AN/A87Librax, NDA 012750214698Dr. Reddy's Laboratories LimitedChlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg5/10/2021NoN/AN/A86Sodium Acetate, NDA 018893214805Milla Pharmaceuticals, Inc.Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials5/4/2021YesNo7/7/202185Thiola, NDA 019569214326Teva Pharmaceuticals USA, Inc.Tiopronin Tablets, 100 mg4/26/2021NoN/AN/A84Librax, NDA 012750214065Alkem Laboratories LimitedChlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg4/26/2021NoN/AN/A83Bentyl, NDA 007961214721Novitium Pharma LLCDicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL4/23/2021NoN/AN/A82Foscavir, NDA 020068213001Gland Pharma LimitedFoscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL)4/21/2021YesNo7/1/202181Thorazine, NDA 009149212144Glenmark Pharmaceuticals LimitedChlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg3/23/2021YesNo3/24/202180Cardizem SR, NDA 019471212317Glenmark Pharmaceuticals LimitedDiltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg3/22/2021YesNo3/30/202179Atropine Sulfate,NDA 209260213424Accord Healthcare Inc.Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial3/19/2021YesNo3/25/202178Lotemax, NDA 020583212450Sun Pharmaceutical Industries Inc.Loteprednol Etabonate Ophthalmic Suspension, 0.5%2/26/2021YesNo5/6/202177Ortho Evra, NDA021180213950AmnealNorelgestromin and Ethinyl Estradiol Transdermal System, 150/35 mcg per day2/25/2021YesNo2/26/202176Northera NDA 203202211818Zydus Pharmaceuticals (USA) Inc.Droxidopa Capsules, 100 mg, 200 mg, 300 mg2/18/2021NoN/AN/A75Lotemax, NDA 202872212080Akorn Operating Company LLCLoteprednol Etabonate Ophthalmic Gel, 0.5%2/10/2021NoN/AN/A75Lotemax, NDA 202872212080Akorn Operating Company LLCLoteprednol Etabonate Ophthalmic Gel, 0.5%2/10/2021NoN/AN/A74Jadenu, NDA 207968214194AmnealDeferasirox Oral Granules, 180 mg and 360 mg2/9/2021NoN/AN/A73Kenalog, NDA 011600212460Perrigo Israel Pharmaceuticals Ltd.Triamcinolone Acetonide Ointment USP, 0.05%2/5/2021NoN/AN/A72Sabril, NDA 020427211539Dr. Reddy's Laboratories LimitedVigabatrin Tablets USP, 500 mg1/29/2021YesNo2/1/202171Eveko, NDA 209905212186Glemark Pharmaceuticals LimitedAmphetamine Sulfate Tablets USP, 5 mg and 10 mg1/27/2021NoN/AN/A70Mexitil, NDA 018873214352RiconPharma LLCMexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg1/25/2021NoN/AN/A69Argatroban, NDA 203049214235Caplin Steriles LimitedArgatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial1/21/2021YesYesN/A68Narcan, NDA 016636213279Aurobindo Pharma LimitedNaloxone Hydrochloride Injection USP, 2 mg/mL (1 mg/mL) prefilled Syringes1/14/2021NoN/AN/A67Taytulla, NDA 204426212706Slayback Pharma LLCMerzee (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg)12/18/2020YesNo1/18/202166Jublia, NDA 203567211827Teva Pharmaceuticals USA, Inc.12/16/2020NoN/AN/A 65Jublia, NDA 203567211851Perrigo Pharma International DACEfinaconazole Topical Solution, 10%12/16/2020NoN/AN/A64Amicar, NDA 015197211629ANI Pharmaceuticals, Inc.Aminocaproic Acid Tablets USP, 500 mg12/14/2020NoN/AN/A63Morphine Sulfate, NDA 022207212451Alkem LaboratoriesMorphine Sulfate Tablets, 15 mg and 30 mg12/3/2020YesNo2/11/202162Depen, NDA 019854212933Lupin LimitedPenicillamine Tablets USP, 250 mg11/30/2020NoN/AN/A61Alinia, NDA 021497213820Rising Pharma Holding, Inc.Nitazoxanide Tablets, 500 mg11/27/2020YesNo12/7/202060Kenalog, NDA 011600213619Cintex Services, LLCTriamcinolone Acetonide Ointment USP, 0.05%11/10/2020NoN/AN/A59Parafon Forte DSC, NDA 011529212743Par Pharmaceutical, Inc.Chlorzoxazone Tablets USP, 750 mg11/2/2020NoN/AN/A58Timoptic-XE, NDA 020330212942Alembic Pharmaceuticals LimitedTimolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%10/22/2020YesNo11/25/202057Librax, NDA 012750213530ECI Pharmaceuticals, LLCChlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg10/20/2020YesNo10/26/202056Kerydin, NDA 204427211848Perrigo Pharma International DACTavaborole Topical Solution, 5%10/13/2020NoN/AN/A55Monurol, NDA 050717212548Xiromed Pharma Espana, S.L.Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet10/6/2020YesNo10/6/202054Firazyr, NDA 022150213054Dr. Reddy's Laboratories LimitedIcatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Pre-Filled Syringe10/5/2020NoN/AN/A53Claritin RediTabs, NDA 021993212795Tenshi Kaizen Private Limited.Loratadine Orally Disintegrating Tablets USP, 5 mg9/18/2020YesYesN/A52Parafon Forte DSC, NDA 011529212053i3 PharmaceuticalsChlorzoxazone Tablets USP, 375 mg and 750 mg9/14/2020NoN/AN/A51Taclonex, NDA 22185212367PerrigoCalcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%9/11/2020NoN/AN/A50Nascobal, NDA 21642212458PerrigoCyanocobalamin Nasal Solution 500 mcg/spray9/9/2020NoN/AN/A49Daptomycin, NDA 208385211403Dr. Reddy's Laboratories Inc.Daptomycin for Injection, 350 mg per vial (single-dose vial)8/31/2020NoN/AN/A48Revatio, NDA 203109213041AptaPharma, Inc.Sildenafil for Oral Suspension, 10mg/mL8/6/2020NoN/AN/A47Cuprimine, NDA 019853211867Dr Reddy's Laboratories, Inc.Penicillamine Capsules USP, 250 mg8/4/2020NoN/AN/A46Metro I.V., NDA 018900212435Gland Pharma LimitedMetronidazole Injection USP, 500 mg/100 mL (5 mg/mL)8/3/2020YesYesN/A45Demser, NDA 017871213734AmnealMetyrosine Capsules USP, 250 mg7/24/2020YesNo7/30/202044Mexitil, NDA 018873213500CrossMedika SAMexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg7/22/2020YesNo7/22/202043Parafon Forte DSC, NDA 011529212898Teva Pharmaceuticals USA, Inc.Chlorzoxazone Tablets USP, 375 mg and 750 mg6/17/2020NoN/AN/A42Albenza, NDA 020666211636Lupin LimitedAlbendazole Tablets USP, 200 mg6/10/2020YesYesN/A41Kenalog, NDA 011600212356Strides Pharma Inc.Triamcinolone Acetonide Ointment USP, 0.05%6/1/2020NoN/AN/A40Revatio, NDA 203109211534Teva Pharmaceuticals USA, Inc.Sildenafil for Oral Suspension, 10 mg/mL5/29/2020NoN/AN/A39Parafon Forte DSC, NDA 011529212185Glenmark Pharmaceuticals LimitedChlorzoxazone Tablets USP, 375 mg and 750 mg5/26/2020NoN/AN/A38Bentyl, NDA 007961212286Hikma Pharmaceuticals USA Inc.Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL5/22/2020YesNo5/22/202037Migranal, NDA 020148212907Cipla LimitedDihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial)5/20/2020YesNo5/23/202036K-Dur, NDA 019439212861AmnealPotassium Chloride Extended-Release Tablets USP, 15 mEq5/8/2020YesYesN/A35Butrans, NDA 021306211586AmnealBuprenorphine Transdermal System, 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour4/14/2020Yes (7.5 mcg/hour); No (20 mcg/hour); No (15 mcg/hour); No (10 mcg/hour); No (5 mcg/hour)No4/16/202034Adrenalin, NDA 204640211880International Medication Systems, LimitedEpinephrine Injection USP, 30 mg/30 mL (1 mg/mL)4/24/2020NoN/AN/A33Narcan, NDA 16636213209Dr. Reddy's Laboratories LimitedNaloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL)3/16/2020YesNo3/18/202032Tepadina, NDA 208264213049MSN Pharmaceuticals Inc.Thiotepa for Injection USP, 15mg/vial and 100 mg/vial3/4/2020NoN/AN/A31Depen, NDA 19854211497Teva Pharmaceuticals USA, Inc.Penicillamine Tablets USP, 250mg2/13/2020YesYesN/A30Mestinon, NDA 15193212702AmnealPyridostigmine Bromide Oral Syrup, USP 60 mg/5 mL1/10/2020NoN/AN/A29Valium, NDA 016087211998Beloteca, Inc.Diazepam Injection USP, 50 mg/10 mL (5 mg/mL)12/26/2019YesYesN/A28Proglycem, NDA 017453211050e5 Pharma, LLCDiazoxide Oral Suspension USP, 50 mg/mL,12/20/2019YesNo12/20/201927Triamcinolone Acetonide, ANDA 089595212384EncubeTriamcinolone Acetonide Ointment USP, 0.05%11/29/2019YesNo12/2/201926Amicar, NDA 15197212492AmnealAminocaproic Acid Tablets USP, 500 mg11/27/2019YesNo12/3/201925Chlorzoxazone, ANDA 40861212253Novitium PharmaChlorzoxazone Tablets USP, 375 mg and 750 mg11/27/2019YesNo11/27/201924Revatio, NDA 203109212440Alkem LaboratoriesSildenafil for Oral Suspension, 10 mg/mL11/27/2019NoN/AN/A23Revatio, NDA 203109212883Ajanta PharmaSildenafil for Oral Suspension, 10 mg/mL11/27/2019NoN/AN/A22Butalbital and Acetaminophen, ANDA 207313213115GranulesButalbital and Acetaminophen Capsules, 50 mg/300 mg11/25/2019YesNo1/30/202021Eryped, NDA 050207211991Par Pharmaceutical Inc.Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg /5 mL and 400 mg/ 5 mL10/23/2019YesYes (400 mg)11/11/2019 (200 mg)20Rapamune, NDA 21083211406ApotexSirolimus Oral Solution, 1 mg/mL10/22/2019NoN/AN/A19Digoxin, NDA 21648213000Novitium PharmaDigoxin Oral Solution USP, 0.05 mg/mL10/4/2019YesNo10/4/201918Elidel, NDA 21302211769GlenmarkPimecrolimus Cream, 1%8/29/2019NoN/AN/A17Orfadin, NDA 21232211041Novitium PharmaNitisinone Capsules, 2 mg, 5 mg and 10 mg8/26/2019NoN/AN/A16Amicar, NDA 15230212780AmnealAminocaproic Acid Oral Solution USP, 0.25 g/mL8/23/2019YesNo8/30/201915Aleve PM, NDA 205352211830ApotexNaproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220/25 mg8/22/2019YesYesN/A14Levocarnitine, NDA 19257211676Novitium PharmaLevocarnitine Sugar Free Oral Solution, 1 g/mL8/14/2019YesNo10/16/201913Daptomycin, NDA 208385212667AccordDaptomycin for Injection, 350 mg/vial7/12/2019YesNo7/16/201912Hemabate, NDA 17989211941Dr. Reddy's LaboratoriesCarboprost Tromethamine Injection, 250 mcg/mL7/2/2019YesNo7/2/201911Cuprimine, NDA 19853210976WatsonPenicillamine Capsule, 250 mg6/24/2019YesNo6/25/201910Revatio, NDA 203109212260Novitium PharmaSildenafil Citrate for Oral Suspension, 10 mg/mL5/31/2019YesNo5/31/20199Navane, NDA 16584211642Novitium PharmaThiothixene Capsules, 1 mg, 2 mg, 5 mg and 10 mg4/5/2019YesNo4/5/20198Methergine, NDA 06035211455TevaMethylergonovine Maleate Tablets, 0.2 mg3/20/2019NoN/AN/A7Mestinon, NDA 15193211694Novitium PharmaPyridostigmine Bromide Oral Syrup, 60 mg/5 mL3/8/2019YesNo3/8/20196Rapamune, NDA 21083211040Novitium PharmaSirolimus Solution, 1 mg/mL1/28/2019NoN/AN/A5Westcort, NDA 01872211750GlenmarkHydrocortisone Valerate Ointment, 0.2 %12/14/2018YesNo1/17/20194Levo-Dromoran, NDA 08720211484VirtusLevorphanol Tartrate Tablet, 2 mg12/13/2018YesNo12/13/20183Amphetamine, ANDA 200166211139AmnealAmphetamine Sulfate Tablet, 5 mg and 10 mg9/26/2018YesNo9/27/2018 (5 mg) 10/1/2018 (10 mg)2Methergine, NDA 06035211483AmnealMethylergonovine Maleate Tablets, 0.2 mg9/10/2018YesNo9/21/20181Potassium Chloride, NDA 206814211067ApotexPotassium Chloride Oral Solution, 20 mEq/15 mL and 40 mEq/15 mL8/8/2018YesNo8/29/2018 (20 mg) 9/7/2018 (40 mg)